발간보고서
home > 자료실> 발간보고서
- 글자크기
2015년 중국 의약품 정책 변화
| 작성자 | 관리자 | 카테고리 | 전문가 인사이트 |
|---|---|---|---|
| 작성일 | 2016-07-20 | 조회수 | 2,828 |
| 원문 | |||
| 출처 | |||
2015년 중국 의약품 정책 변화
- 글 쑨쉐메이
(Sun Xuemei) - 상임 컨설턴트
컨설팅 분야
- 중국 인허가, 임상
- 중국 사업개발, 기술 마케팅 등
주요 약력
- 2011-현재 Beijing Lewei Biological & Technology Co. Ltd, Senior Consultant
- 2009-2011 Shanghai Johnson & Pharmaceuticals, Ltd., Regulatory Affairs Director
- 2005-2009 Wyeth Pharmaceutical Co. Ltd., Associate Director of Regulatory Affairs
- 2001-2005 Xian-Janssen Pharmaceutical Ltd., Manager of Regulatory Affairs
- 1994-1996 Su Zhou Lederle Pharmaceutical Co., Sales Supervisor
- 1991-1993 HaErbin BinKai Pharmaceutical Co., Director of Pharmaceutical Science Centre
중국 의약품산업에서 2015년은 중국 의약품 품질이 개선되는 한 해였다. 의약품관리법(药品管理法)이 수정되고 중국약전(中国药典) 2015년판이 발표되었으며 일련의 의약품 심사평가 규정이 개혁되었다. 이는 과학적인 방법을 통해서 의약품 품질을 관리 감독하고 빠르고 포괄적으로 의약품 품질을 높이려는 조치였다. 우리는 2015년 새로운 법규를 기반으로 2016년 의약품 심사 평가의 혁신, 신약 심사 속도 향상, 제네릭 제품의 연구 및 생산 품질 제고 등 다양한 조치가 조속히 실현될 것이라 믿는다. ‘Take you to see china’는 정보 공유를 위해 마련되었다. 중국 의약품 산업에 참여할 준비가 되었다면 함께 중국 국가식품약품감독관리총국(国家食品药品监督管理总局, 이하 CFDA)의 개혁안을 함께 살펴보도록 하자. 이 같은 정보 공유로 여러분의 합리적인 전략 수립에 도움이 되리라 생각한다.
Highlights of Regulatory News
The 14th meeting of the 12th standing committee of the National People's Congress in China made the decision to revise the Drug Administration Law (DAL) (2015/04/24, Xinhua News Agency, News)
On April 24, 2015, the 14th meeting of the 12th standing committee of the National People's Congress in China made the decision to revise the Drug Administration Law (DAL) which will come into force from the date of release. The DAL will be revised correspondingly and re-released according to this decision.
There are five changes in this revision involving Article 7, 14, 55, 89, 100. The specific details are summarized as follows:
- (1) Deleting “each drug manufacturer shall rely on the Drug Manufacturing Certificate to be registered with the administrative department for industry and commerce” from Paragraph 1 of Article 7;
- (2) Deleting “each wholesaler and retailer shall rely on the Drug Supply Certificate to be registered with the administrative department for industry and commerce” from Paragraph 1 of Article 14;
- (3) Deleting Article 55 “For drugs the prices of which are fixed or guided by the government according to law, the competent pricing department of the government shall, on the pricing principle stipulated in the Pricing Law of the People’s Republic of China and on the basis of average social cost, supply and demand in the market, and public affordability, rationally fix and adjust the prices, in order to ensure that price is commensurate with quality, eliminate excessively high price, and protect the legitimate interests of users.” ;
- (4) Re-designating Article 89 as Article 88 and deleting the words “Article 57” from the latter; and
- (5) Accordingly, deleting Article 100 “Where a Drug Manufacturing Certificate or Drug Distribution Certificate is revoked in accordance with this Law, the drug regulatory department shall notify the administrative department for industry and commerce to alter or cancel the registration”.
The revision this time is small revision to cooperate with the reform of the administration of industry and commerce and the drug price management. Delete the prerequisite of possessing cost recovery to register for business License . Delete the government pricing and government guidance pricing in drug pricing management. “Major revision” to the DAL still need time.
Source : http://news.xinhuanet.com/2015-04/24/c_1115085395.htm
Notification on Printing and Distributing the Guiding Principle for Risk Evaluation during On-site Inspection of Pharmaceutical Production (2015/04/24, CFDI, Notification)
On 24th Apr. 2015, CFDA reissued Notice on Printing and Distributing the Guiding Principle for Risk Evaluation during On-site Inspection of Pharmaceutical Production which had been already released on 11th May 2014. The principle of risk assessment is laid down in this guiding principle, the drug administration department shall classify the discovered defects into “critical defects”, “major defects” and “common defects” in accordance with risk level during on-site inspection of enterprises to conduct scientific evaluation. The annex lists some cases of defects and their classification, for the purpose of setting a standard for drug inspection behavior. This guiding principle is applicable to the medicine GMP authentication inspection, follow-up inspection and relevant inspections organized by the drug administration department; during the flight inspection of drug, this guiding principle can also be employed for the inspection and decision where the implementation of medicine GMP is involved.
Source : http://www.cfdi.org.cn/ccdweb/main?fid=open&fun=show_news&from=view&nid=6575
State Council released Notification on the Summary of 2014 and Key Tasks of 2015 on Healthcare System Reform (2015/04/26, State Council, Notification)
State Council released Summary of 2014 and Key Tasks of 2015 on Healthcare System Reform on April 26th, 2015. In this document, the 2014 summary part gives a overview picture of healthcare system reform from the aspect of multi-ministry cooperation and specific projects. The 2015 tasks part is divided into 7 aspects in which the fourth aspects, “improving the drug supply mechanism”, is very critical to drug registration.
The key points in the fourth aspects follow:
- (1) To deepen the reform in drug manufacturing and distribution fields, promoting the industry to improve the drug innovation capability and optimize the industrial structure accordingly.
- (2) To expedite and formulate the encouraging policy of pediatric drugs and to explore measurements to guarantee supply of orphan drug.
- (3) To promote the connection of medical information system with national drug e-supervision system.
- (4) To improve the review system of innovation drug and medical device.
- The improvement of special review procedure and technical review system will be beneficial to the review of innovative drug and medical device. The 2015 national drug registration meeting gives a more detailed explanation of the improvement of special review system as one of the important task of 2015, which is adjusting the scope of special review and involving the innovation drug used to treat HIV, malignant tumor, serious infectious disease and rare disease with unmet medical need into special review path. In this way, the approval of innovation drug with unmet medical need can be encouraged and accelerated. It should be noted that not all of the innovation drugs will be qualified for priority review or encouraged by CFDA.
- The capability of technical review and the transparency of evaluation will be raised.
- The acceptance and review of ANDA will be stricter on limiting the application of “low-level redundant drug”. The generic drug, whose data is not sufficient or cannot prove the safety, efficiency, quality and quality consistency evaluation, will not be approved and not allowed to resupply additional information.
- The quality consistency evaluation for generic drug will be carried forward in order to enhance the generic drug quality.
- The pilot program of MAH will be performed.
The above task is designed to CFDA and NHFPC. For further specific suggestions of drug and medical device review system reform, CFDA submitted Review System Reform of Innovation Drug and Medical Device (revised version ) to State Council in April 2015.
Source : http://www.gov.cn/zhengce/content/2015-05/09/content_9716.htm
The official notice of further regulating standard acceptance work of import drug registration from CFDA(2015/12/17, CFDA, Notice)
In order to regulate the acceptance of import drug registration, the relevant issues are hereby
announced as follows:
- 1. New drugs application
- (1) Registration of general or specific immune globulin for intramuscular injection. Applicant should submit a statement for this kind of registration when submit NDA/IND, and also fill clearly in the relevant category of the ‘special declaration items’.
- (2) Add new indication to category1.6 and 3.4 of chemical drugs. Import drugs application should follow the procedure and requirements of current regulations.
- 2. Generic drugs application: Import drugs application should follow the procedure and requirements of current regulations.
- 3. Other related issues
- (1) Generic drugs application: Import drugs application should follow the procedure and requirements of current regulations.
- (2) Change the registered agency of import drugs: Change the registered agency of import drugs, which belongs to category 28 of supplementary application, should submit for the record.
Technical evaluation
China Food and Drug Administration Center for Drug Evaluation Issued Overview on the Review of Pasireotide Diaspartate for Injection (2015/04/24, CDE, Announcement)
Cushing’s syndrome (CS), also known as hypercortisolism, is a symptom complex due to prolonged exposure to an excess of cortisol produced by the adrenal cortex. It has a global annual incidence of 1-3 in million. The massive epidemiological data in China is not yet available. However, the overall incidence does not vary significantly with region and race. Research showed that the mortality in patients with Cushing’s syndrome was four times higher than that in normal population; and for patients who could not be cured by surgical therapy, the mortality increased significantly to at least five times of that in normal population.
[Current status of treatment]
Pituitary tumor resection is the main therapeutic approach to Cushing’s syndrome at present, with a operation failure rate of 8% - 31% and a post-operative recurrence rate of 5% -34%. So far, no therapeutic agents for Cushing’s syndrome have been approved in China.
[Product characteristics]
Pasireotide is a somatostatin analog which can reduce the production of cortisol by inhibiting ACTH secretion to lower the levels of urinary free cortisol (UFC) and the serum levels of cortisol. This product was first approved under trade name “Signifor” by EU Drug Administrative Authority on April 25, 2012 according to relevant regulations of rare disease. Hereafter, it was successively approved in 48 countries. The Pasireotide Diaspartate for Injection to be approved in China has the dosage form of Parireotide subcutaneous injection, which is indicated for adult CS patients who cannot choose pituitary tumor resection or who have not been cured by the surgery.
[Clinical trials with registration purpose]
The studies supporting the approval of this product in China were clinical trials CSOM230B2305 (phase III) and CSOM230B2116 (phase I). CSOM230B2116 was a single-center and open-label phase I clinical trial completed in China, which evaluated the pharmacokinetics and safety of single-dose administration in healthy Chinese volunteers. The results showed that drug exposure of Pasireotide increased proportionally to the dose within dosage range of 300μg - 900μg; there was a mild drug accumulation (1.39 to 1.53 times) after twice daily and multiple-dose administration, and no clinically significant racial differences were discovered. Racial sensitivity was also not observed during subsequent evaluation of population pharmacokinetics.
CSOM230B2305 was a phase III global pivotal study, which was a multi-center randomized study conducted in patients who still suffered from persistent or recurrent Cushing’s syndrome after surgery for pituitary tumors, or therapy-naive CS patients due to inoperable tumors or their refusal to surgery, to evaluate the safety and efficacy after six months treatment with subcutaneous injection of Pasireotide at different doses (600μg b.i.d and 900μg b.i.d). This study recruited 162 patients with baseline of 24-hour urinary free cortisol (UFC ) > 1.5 x normal limit (ULN) .The results showed, Pasireotide effectively reduced the high level cortisol in CS patients and significantly improved their symptoms and signs of hypercortisolism. Twenty Chinese patients with Cushing’s syndrome were included in this study, and the analysis and comparison of Chinese subgroups showed that Pasireotide demonstrated consistent efficacy and safety in Chinese patients as that in the whole population. The results of this study have confirmed that Pasireotide is an effective and well tolerable drug for Chinese patients with Cusing’s syndrome. The most common adverse events (> 15%) were diarrhea, nausea, hyperglycemia, cholelithiasis, headache, abdominal pain, fatigue and diabetes mellitus, but the safety risks were controllable. [Registration review & evaluation] The IMCT of this product was submitted in China in May 2007; and the IMCT approval was obtained in February 2008. After the completion of IMCT study, the NDA (i.e., NDA (I) of existing 3 submissions and 3 approvals) supported by Chinese PK and IMCT data were submitted in September 2012, then CFDA issued the Clinical Trial Approval in October 2014. Afterwards, another NDA (i.e., NDA (II) of existing 3 submissions and 3 approvals) supported by Chinese PK and IMCT data was submitted in November 2014, which passed CDE review in April 2015, then obtained NDA approval in China on May 13th, 2015. During the CDE review, panel meeting were held. The conclusion is that Cushing’s syndrome indeed belongs to a rare disease with a very low prevalence (annual incidence rate 1-3/million), and the number of patients with inoperable CS or operably incurable CS is much lower; and the patients usually has many complications with a high mortality; so far, there has been no effective remedy for this disease. Pasireotide is the only approved etiological therapeutic globally for the moment; and it has been marketed in many countries/regions including U.S.A and Europe. The global pivotal study for registration demonstrated, this product had consistent efficacy and safety in Chinese subgroup with that in the whole population; and that there were no clinically significant racial differences on the pharmacokinetics between Chinese population and the western population. To conclude, the existing data can support its approval for use in such patients in China.
[Post-marketing requirements]
This product is conditionally approved; and meanwhile, the following requirements for post-marketing studies are specified in the Clinical Trial Approval of Import Registration.
(1) After launch, further standard clinical studies should be conducted in China to evaluate the long-term efficacy and safety with patient number not lower than 100; and the period of drug administration period should be at least six months; in addition, the efficacy, safety and dose should be evaluated.
(2) Given the lack of effectiveness data on dosage regimen of 0.3mg, twice daily, it is advised that information should be collected after launch to analyze the effectiveness of this dosage regimen;
(3) It is advised that immunogenicity studies should be conducted after launch to investigate the production probability of ADA that can potentially affect the efficacy and safety of this product, as well as its effects.
Source: http://www.cde.org.cn/reviewDe.do?method=showFAQ&id=130
Notice of Basic Principles for Priority Review Designation for Pediatric Drug Application for Urgent Unmet Medical Needs(2015/12/21, CDE, Notice)
This guideline is based on the seventh content of the announcement of which to speed up the approval of clinical urgent need, and to implement children's drug registration application in a separate line to speed up the review and approval. And the announcement is approval of a number of policy on drug registration review announcement issued by CFDA on November 11, 2015 (2015 230th). Any comments can be provided to CDE in written with justifications, the commenting period is from Dec 21 to 28, 2015.
The basic principles are as following:
1. For new drug applications, one of the below criteria should be met with:
(1) An application concerning life-threatening diseases or for diseases affecting the growth and development of children, with no effective treatment drugs or therapeutic methods currently available;
(2) Can show significant treatment advantages compared with existing treatments.
2. For applications of new dosage form or new strength(s), the following conditions should be met at the same time:
(1) An application of drug product whose existing package inserts already have clear message of “administration and dosage for children”;
(2) An application of drug product whose existing dosage form or strength is not appropriate to children yet the newly added dosage form or strength is applicable to children.
3. Application of generic drug:
For pediatric drugs that are currently in the shortage of market supply, priority review and approval should be granted. Where multiple manufacturers of a generic drug apply at the same time, priority review shall be granted to the first applicant according to the queuing of applications by the sequence of the time of submission; if an application does not meet requirements after the review, its priority will be disqualified, and the subsequent application of the same product may supplement and replace based on the order in queue. Together with the draft principles, CDE released the first batch of priority review products with justifications for hearing as well. There are total 10 products involved, 9 of them are domestic, 1 is imported drug.
Source : http://www.cde.org.cn/news.do?method=viewInfoCommon&id=313511
Quality Control
CFDA’s Announcement on Related Matters of Implementing Pharmacopoeia of the People's Republic of China 2015 (2015/07/15, CFDA, Announcement)
The No.105 Announcement has been issued by CFDA on July 15, 2015. The related matters of implementing Chinese Pharmacopoeia 2015 have been clearly announced in the document, which has been summarized as follows:
- (1) Reiterate the status of Chinese Pharmacopoeia as the statutory technical standard;
- (2) All the drugs on the market should follow relevant general requirements of this Pharmacopoeia including general notices, monographs and general rules since December 1, 2015;
- (3) As for the drugs recorded in Chinese Pharmacopoeia 2015, all the national drug standards on the same drugs recorded in the previous editions and issued by the CFDA (or MOH, Ministry of Health) will be abolished since December 1, 2015; As for the drug product strengths which are not recorded in Chinese Pharmacopoeia 2015, their specifications should be implemented according to the same drug product of this Chinese Pharmacopoeia; As for the drugs which are no longer recorded in Chinese Pharmacopoeia 2015 but recorded in previous editions, the former pharmacopoeia standard will continue to be implemented before the new standards are issued, but it should meet the general requirements of the new pharmacopoeia;
- (4) If the test items recorded in the drug registration specification are more than (different from) those in the pharmacopoeia or the specification is stricter than the pharmacopoeia, the respective items and parameters of the former registration specification should be followed on the basis of implementing the pharmacopoeia requirements; If the test items recorded in drug registration specification are less than those in the pharmacopoeia or the specification is lower than the pharmacopoeia, the pharmacopoeia should be followed; If there are differences in test items caused by excipients and manufacturing processes, the manufacturer should carry out study and submit supplementary drug applications if necessary;
- (5) The drugs which are approved before the June 5, 2015 (including the day) should implement corresponding requirements in the new pharmacopoeia since December 1, 2015. If changes in drug formulations and manufacturing processes are involved, supplementary applications should be submitted to CFDA before December 1, 2015. During the review and approval, the former specification can be implemented. If only changes in specific test items and parameter limits are involved, application should be submitted before December 1, 2015 for filing.
- (6) For drug registration applications submitted after June 5, 2015 (excluding the day), research should be carried out according to the requirements of the new pharmacopoeia, and application dossiers should be submitted. The technical review department will carry out review according to the new pharmacopoeia.
For registration applications which are accepted before June 5, 2015 (including the day) and their technical review has not been completed by the technical review department, the technical review work should be carried out according to the new pharmacopoeia; for those which have completed the technical review by the technical review department, the drugs should meet the requirements of new pharmacopoeia within 6 months of the drug marketing approval. - (7) According to the supplemented and revised contents of Chinese Pharmacopoeia 2015, drug manufacturers should submit supplementary applications for changing drug package inserts and labels in time before the deadline specified above. The drugs manufactured after the deadline should use the changed package inserts and labels. For drugs with generic names changed, old names can be used as former names for transition.
Administrative Fees
The National Development and Reform Commission (NDRC) and Ministry of Finance (MOF) have published the notice on Revised Administrative Fees of Food and Drug Authorities under the Administration of the Central Government and the Administration on Registration Fee for the Drug and Medical Device (2015/04/21, 2015/05/12, NDRC&MOF, Notification) The China Food and Drug Administration (CFDA) have published the Announcement of the Registration Pricing Standards of Drugs and Medical Devices (2015/05/27, CFDA, Announcement)
Series of regulation relevant to Registration Pricing Standards of Drugs and Medical Devices have been issued and implemented from the end of April to May in 2015. Notice on Revised Administrative Fees of Food and Drug Authorities under the Administration of the Central Government (Notice on Administrative Fees) was published by NDRC and MOF on April 21, 2015, which further regulate the administration of administrative fees for Drug registration, Medical device registration, Certification, Drug protection, Testing and Narcotic or psychotropic drug import or export license. Also, to encourage the innovation, this notice also contains the relevant terms of the waiver charges, like for any small-sized or micro enterprise which meets the relevant requirements of the Rules for Classification of Small and Medium-sized Enterprises (Doc. MIIT Lian Qi Ye [2011] No.30), no new drug registration fee will be imposed when it applies for registration of any new drug. Administration on Registration Fee for the Drug and Medical Device has been published by NDRC and MOF on May 12, 2015, and the key points are,
- (1) The definition of drug & medical device registration fee: Food and Drug Administration Department levy the expenses of acceptance, reviewing, on-site examination (GMP inspection for Medical Device) on the applicant who apply the drug and medical device registration.
- (2) The composition of registration cost: labor cost, travel expense, conference expense, maintenance expense for information and materials, rent and property management fee, instrument depreciation expense etc., the benchmark of registration fee: drug or medical device registration fee=standard expense per person per day * the number of labor for registration * the working day. The standard expense per person per day does not exceed 2400RMB/person/day.
- (3) The tariff in Province level: the tariff of drug and medical device registration generated by Department of Finance according to relevant regulations.
- (4) Additional fees for import products (drugs and medical devices): additional overseas on-site examination expense such as traffic expense, board and lodging expense and incidental expenses.
- (5) Fees adjustment: a routine revaluation in every 5 years, adjustment according to evaluation. The Registration Pricing Standards of Drugs and Medical Devices was issued and effected by CFDA, on 27-May-2015. It described that the enterprise bear all the costs, including labor expense and material resources in respect of drug and medical device registration application, reviews and approval. The adjustment of the charges is in accordance with the principle of cost recovery. The original tariff for the drug registration was formulated by National Development & Reform Commission and Ministry of Finance in 1995, and free for medical device registration.
Due to salary increase and price inflation, the fee is too low. The new fee levels are increasing significantly while still low in comparison with other markets. For new imported drugs, only around RMB 624,000 .the fee is about 64% of Australian requirement, 35.5% of Canadian requirement, 33.7% of Japanese requirement and 5.2% of United States requirement. Notice dated on May 27th 2015 contains three annexes which are the Pricing Standards for the Registration of Drugs and Medical Devices, Implementing Rules for Drug Registration Pricing (For Trial Implementation) and Implementing Rules for Medical Device Registration Pricing (For Trial Implementation). The comparison table between the implemented price and previous price is as below.
Drug registration fees shall be collected based on an individual active pharmaceutical ingredient (API) or preparation as a product. If a specification is added, an additional 20% registration fee shall be collected according to relevant category. Where an applicant applies for one-off imported drugs, the drug registration fee of RMB 2,000 yuan shall be charged.
Source:
http://szs.mof.gov.cn/zhengwuxinxi/zhengcefabu/201505/t20150505_1227072.html
http://www.sdpc.gov.cn/gzdt/201506/t20150602_694719.html
http://www.sfda.gov.cn/WS01/CL0087/120201.html
Others regulatory
<Summary of Administrative Approval Service Guidance on Human Genetic Resources Gathering, Collection, Buying and Selling, Export and Exit> (No.117 2015) (2015/07/03, MOST, Guideline )
On July 3rd, 2015, The Ministry of Science and Technology published . This guideline matches with the (1998) and aims to guide and streamline the declaration behaviors of enterprises, and to regulate administrative permission. It was compiled on the basis of relevant stipulations of the and , etc. This guideline covers the information of scope of application, acceptance institution, submission dossier, procedures and approval timeline, etc.
The guidance reiterates and stipulates that any international cooperation involving the human genetic resources gathering, collection, buying and selling, export should be filed at MOST in accordance with the request of guidance. That’s to say all MNC-sponsored clinical trials that require gathering, collection, buying and selling, export and exit of human genetic resources should be filed at MOST. It’s applicable not only for new clinical trials, but also on-going clinical trials. If any activity or behavior which should be declared per relevant laws and regulations is found not declared, it will be recorded in the integrity system of both Ministry of Security and Ministry of Public Security (the "Black list").
As for the approval timeline mentioned in the guidanc e where it says ―the MOST will release approval letters within 3 months once receiving acceptance letters (since from acceptance date)‖, it has covered the experts’ review timeline. MOST plans to take several measures to speed up the review and approval process.
As mentioned in the guidance, the applicant must be a legal entity established in accordance with the law in China, which would facilitate the centralized control under government. It’s not allowed for foreign sponsor or CRO, etc. to apply.
Source: http://www.most.gov.cn/tztg/201507/t20150703_120547.htm
Notice of General Office of Ministry of Science and Technology about Practicing Administrative Permission of Gathering, Collection, Buying & Selling, Export and Exit of Human Genetic Resources (2015/08/24, MOST, Notice) General Office of Ministry of Science and Technology Issued Notice on Carrying out Related Work about National Inspection to Investigate the Real Situation of Management of Human Genetic Resources (2015/09/17, MOST, Notice)
Since 1998, the Ministry of Science and Technology (MOST) has been practicing administrative permission review and approval over international cooperative programs involving human genetic resources following the Interim Provisions on Management of Human Genetic Resources (No.: National Development Office [1998] 36) promulgated by the MOST General Office. In 2015, MOST, with a view to enhancing management and guaranteeing safety of human genetic resources in our country, standardized and improved the former administrative permission of human genetic resources. The administrative permission item is renamed as "review and approval of gathering, collection, buying & selling, export and exit of human genetic resources". Since October 1, 2015, MOST has been formally accepting administrative permission review and approval applications under the new title, and the former "review and approval of international cooperative programs involving human genetic resources" has been included into administrative permission under the new title. Meanwhile, MOST has prepared the Guide for Administrative Permission Services for Review and Approval of Gathering, Collection, Buying & Selling, Export and Exit of Human Genetic Resources (hereinafter referred to as "Guide"), which was released on August 24, 2015. "Guide" makes clear the scope of application of the administrative license, the application conditions, information requirements, approval process and timeline, which suitable for the task engaged in the gathering, collection, buying & selling, export and exit of human genetic resources. On September 17, 2015, the MOST General Office issued the Notice on Carrying out Related Work about National Inspection to Investigate the Real Situation of Management of Human Genetic Resources (hereinafter referred to as "Notice"). The MOST Department of Social Development and Department of Policies, Regulations and Supervision, jointly with China National Center for Biotechnology Development, have decided to carry out a national inspection to investigate the real situation of management of human genetic resources during September and October of 2015. The inspection will cover 145 applicants of 658 international cooperative programs involving human genetic resources reviewed and approved by MOST and include fulfillment of the Interim Provisions on Management of Human Genetic Resources and the Notice of Ministry of Science and Technology on Further Enhancing Management of Human Genetic Resources in each organization as well as each organization's regulations on management of human genetic resources related activities. Inspection methods include undertaker self-inspection, site inspection and localized inspection. Arrangement and detailed requirements of site inspection and localized inspection will be otherwise announced. Regarding undertaker self-inspection, the Notice requires that self-inspection reports should be submitted to the corresponding competent departments of science and technology at the provincial level or the corresponding superior administrative departments; related departments should forward pooled reports to MOST before October 20. Each inspection group should complete the inspection work before October 31, 2015 and submit inspection reports within 15 days after completion of inspection. MOST planned to formally accept administrative permission review and approval applications under the new title via the online application system from October 1, 2015. However, the online application system is still being debugged. Therefore, MOST issued an urgent notice on October 8, announcing that printed dossiers are acceptable to apply for administrative permission of management of human genetic resources. The launch time of the application system will be otherwise announced.
Source:
http://www.most.gov.cn/mostinfo/xinxifenlei/fgzc/gfxwj/gfxwj2015/201509/t20150930_121850.htm
http://www.most.gov.cn/mostinfo/xinxifenlei/fgzc/gfxwj/gfxwj2015/201509/t20150925_121797.htm
http://www.most.gov.cn/tztg/201510/t20151008_121908.htm
본 내용에 대해 의견이 있다면 다음의 이메일로 좀 더 깊은 이야기를 나누었으면 좋겠다.
Email address：sunnysun@khidi.or.kr(쑨쉐메이), xiujing0711@khidi.or.kr(코디 이수정)
- 이전글 이전글이 없습니다.
- 다음글 다음글이 없습니다.
